(108 days)
The Spectral MD DeepView system is intended for studies of blood flow in the microcirculation. The DeepView system is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, physiology, neurosurgery and anesthetics.
Deep View system-based technology combines real-time digital analysis of optical signatures, thereby sensitizing an imager to photon-tissue interactions deep below the skin's surface. These image signatures are unique to the body and relate directly to a person's dynamic nature - both in terms of the quantity and quality of important physiological properties. This technology is non-invasive and uses no harmful radiation such as X-rays and allows clinical investigators to look deeper into the body, delivering images of blood flow under the skin's surface without ever touching the patient.
The DeepView system is composed of a mobile cart with uninterruptible power supply, a laptop computer with remote multimedia keyboard, an LCD screen mounted on a bracket that allows for side-to-side panning, a mechanical arm, a CMOS camera with DSP electronics, and disposable LED cartridges with an associated LED driver control board.
The provided document describes the DeepView Digital Video Physiological Portable Imaging System, a device intended for studies of blood flow in the microcirculation. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and proving performance against them in a de novo study.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative blood flow measurements) that the DeepView device needed to meet. Instead, the study's goal was to demonstrate substantial equivalence to existing predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Ability to detect blood flow optically | DeepView uses optical methods to detect blood flow and pulse pressure. |
| Ability to detect pulse frequency | DeepView was tested alongside predicate devices to show substantial equivalence in detecting pulse frequency. |
| Ability to produce flow images | DeepView displays 2D color images demonstrating relative blood flow, similar to moorLDI and moorLDI2-IR. |
| No new issues of safety and efficacy compared to predicate devices | Comparison testing conducted demonstrates that the DeepView is substantially equivalent and does not introduce any new issues of safety and efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document mentions "comparison testing" which included "camera distance testing and tissue phantom testing." This implies the use of a controlled test environment (tissue phantoms) rather than human subjects. No specific number of phantoms or test cases is provided.
- Data Provenance: The testing appears to be conducted in a laboratory setting using "tissue phantoms." There is no mention of human data, country of origin, or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this submission. The ground truth for the comparison testing seems to be the performance of the predicate devices themselves, as the DeepView's output was compared to theirs. There's no indication of independent expert review to establish a separate "ground truth" for the test set.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of human-in-the-loop assessment or expert adjudication for the "comparison testing." The comparison was against the output of the predicate devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or reported. This submission focuses on the standalone device's equivalence to existing technology, not on improving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the testing described appears to be a standalone performance evaluation of the DeepView device against the predicate devices. The "comparison testing" suggests the DeepView's output was directly compared to the outputs of the moorLDI, moorLDI2-IR, and Avant 9600. The device's ability to "detect blood flow and pulse pressure" and produce "2D color images of relative perfusion distribution" constitutes its standalone performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the comparison testing was effectively the performance of the predicate devices. The DeepView was evaluated for its ability to produce similar results (detect blood flow, pulse frequency, and produce flow images) to the already legally marketed and accepted predicate devices (moorLDI, moorLDI2-IR, and Avant 9600). For the tissue phantom testing, the "ground truth" would implicitly be the known properties of the phantoms and the expected measurements, as validated by the predicate devices.
8. The Sample Size for the Training Set
Not applicable. As this is a 510(k) premarket notification for a device using established optical principles, there is no mention of an "AI algorithm" requiring a training set in the contemporary sense. The device's operation is based on "real-time digital analysis of optical signatures" and "non contact Photoplethysmography (PPG)," which points to signal processing rather than machine learning models that require training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set or an AI algorithm that would require one.
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※Spectral MD™
5. 510(k) SUMMARY
K124049
APR 1 8 2013
| Submitter: | Spectral MD TM, Inc.5959 Harry Hines Blvd.Professional Office Building 1, Suite 426Dallas, Texas 75235 | APR 18 20 |
|---|---|---|
| Contact Person: | Mr. Kenneth L. BlockVP Quality and Regulatory AffairsTEL: 972-499-4934FAX: 972-767-4325block@spectralmd.com | |
| Date Prepared: | December 28, 2012 revised March 25, 2013 | |
| Trade Name: | DeepView Digital Video Physiological Portable Imaging System | |
| Common Name: | Extravascular Blood Flow Probe | |
| Classification Name: | DPT 870.2120 Probe, Blood Flow, ExtravascularDQA 870.2700 Oximeter | |
| Predicate Device: | K980383 Moor Instruments - moorLDI Laser Doppler ImagerK032841 Moor Instruments - moorLDI2-IR Infrared Laser Doppler ImagerK023044 Nonin - Avant Model 9600 Pulse Oximeter | |
| Device Description: | Deep View system-based technology combines real-time digital analysis of opticalsignatures, thereby sensitizing an imager to photon-tissue interactions deep belowthe skin's surface. These image signatures are unique to the body and relate directlyto a person's dynamic nature - both in terms of the quantity and quality of importantphysiological properties. This technology is non-invasive and uses no harmfulradiation such as X-rays and allows clinical investigators to look deeper into thebody, delivering images of blood flow under the skin's surface without evertouching the patient.The DeepView system is composed of a mobile cart with uninterruptible powersupply, a laptop computer with remote multimedia keyboard, an LCD screenmounted on a bracket that allows for side-to-side panning, a mechanical arm, aCMOS camera with DSP electronics, and disposable LED cartridges with anassociated LED driver control board. | |
| Statement ofIntended Use: | The Spectral MD DeepView system is intended for studies of blood flow in themicrocirculation. The DeepView system is suitable for a wide variety of clinicalapplications including plastic surgery, diabetes, dermatology, vascular surgery,wound healing, neurology, physiology, neurosurgery and anesthetics. |
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≥Spectral MD"
Summary of Technological Characteristics:
The DeepView uses infrared light to detect pulsatile blood flow in patients, and then provides 2D color images of relative perfusion distribution to healthcare providers. The technology used is non contact Photoplethysmography (PPG). PPG allows the DeepView to take advantage of the deep penetration of near IR light in human tissue.
The DeepView, as well as all three predicate devices, is portable and use software to control the device operations, collect the patient data, analyze the data, present the data to the user, etc. The DeepView displays 2D color images demonstrating relative blood flow, similar to the moorLDI and moorLD12-1R predicate devices. The new device and the three predicate devices can all store patient data, which can then be examined later by healthcare professionals.
The DeepView and the moorLDI and moorLDI2-IR are non-contact regarding patient interaction. All devices (new and predicate) require light and optics for detection of blood flow. The two predicate imaging devices (moorLDI and moorLD12-1R) use laser illumination, while the DeepView device and predicate Avant 9600 device use LED illumination.
Summary of Test Data:
Direct comparison testing was performed with both the moorLDI and Avant 9600 predicates. Comparison testing was conducted to demonstrate that the DeepView can, using optical methods, detect blood flow and pulse pressure. Using these attributes, DeepView was tested alongside the predicate devices to show substantial equivalence in detecting pulse frequency and in producing flow images. Comparison testing included camera distance testing and tissue phantom testing.
The comparison testing conducted demonstrates that the DeepView is substantially equivalent to the predicate devices identified and does not introduce any new issues of safety and efficacy.
Conclusion:
Spectral MD™, Inc. considers the DeepView to be substantially equivalent to the predicate devices listed above This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure with outstretched arms, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 18, 2013
Spectral MD™, Inc. % Ken Block Consulting Ms. Diane Rutherford, BSME, MSMSE 1201 Richardson Drive, Suite 280 Richardson, Texas 75080
Re: K124049
Trade/Device Name: DeepView Digital Video Physiological Portable Imaging System Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular blood flow probe Regulatory Class: Class II Product Code: DPT Dated: March 25, 2013 Received: March 28, 2013
Dear Ms. Rutherford:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Diane Rutherford, BSME, MSMSE
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
PeterDi Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: K124049
Device Name: DeepView
Indications for Use:
The Spectral MD DeepView system is intended for studies of blood flow in the microcirculation. The DeepView system is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, neurosurgery and anesthetics.
| Prescription Use | X | AND/OR | Over-the-Counter Use |
|---|---|---|---|
| (21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
| Neil R Ogden | |
|---|---|
| 2013.04.16 15:13:45 -04'00' | |
| (Division Sign-Off) for MXM | |
| Division of Surgical Devices | |
| 510(k) Number | K124049 |
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).